Abstract: The present invention relates both to a new reference material based on a blood matrix for use in diagnostics or in-vitro diagnostics, in particular those using sequencing methods of nucleic acids, such as polymerase chain reaction (PCR) or next generation sequencing (NGS), and to a method for its production including validation, in particular a non-invasive liquid biopsy (liquid biopsies).

Abstract: The present invention relates to a new method for determining the allele frequency and/or mutation rate in nucleic acids, in particular in tumor nucleic acids, in the context of a polymerase chain reaction (PCR), and to diagnostics for this purpose, wherein at least one reference nucleic acid (RN) and one mutation sequence with respect to the reference nucleic acid are used. This reference nucleic acid and mutation sequence allows polymerase chain reaction (PCR) methods to be validated, in particular on the basis of device parameters and sample preparation. Furthermore, the invention relates to an associated diagnosis and prognosis method, in particular for tumor diagnosis as part of a liquid biopsy.

Abstract: The present invention provides a diagnostic device allowing highly specific and efficient in vivo and/or in vitro detection of a bio marker in a broad range of bodily fluids or tissues. The diagnostic device is composed of a binding agent that specifically binds a bio marker present in the bodily fluid linked by a linker compound or layer to the substrate, which includes a metallic, a semiconductor, or a polymeric carrier. The present invention further provides methods using said device for the detection of bio markers, as well as kits comprising said device and suitable ingredients for the detections of bio markers in a bodily fluid. Furthermore, the invention provides suitable in vivo and in vitro applications of said binding agent for the detection of specific disease-related target structures.

Abstract: The present invention provides a diagnostic device allowing highly specific and efficient in vivo and/or in vitro detection of a bio marker in a broad range of bodily fluids or tissues. The diagnostic device is composed of a binding agent that specifically binds a bio marker present in the bodily fluid linked by a linker compound or layer to the substrate, which includes a metallic, a semiconductor, or a polymeric carrier. The present invention further provides methods using said device for the detection of bio markers, as well as kits comprising said device and suitable ingredients for the detections of bio markers in a bodily fluid. Furthermore, the invention provides suitable in vivo and in vitro applications of said binding agent for the detection of specific disease-related target structures.